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NCT Number: NCT05918224

Streptococcus Salivarius K12 for Prevention and Treatment of Oral Mucositis in Patients Undergoing Radiotherapy

To evaluate the efficacy and safety of Streptococcus salivarius K12 for prevention and treatment of oral mucositis in patients undergoing radiotherapy for malignant head and neck tumors.

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Key information

Conditions

Head and Neck Squamous Cell Carcinoma Carcinoma Carcinoma, Squamous Cell Head and Neck Neoplasms Mouth Diseases Nasopharyngeal Carcinoma Nasopharyngeal Diseases Nasopharyngeal Neoplasms Neoplasms Neoplasms by Histologic Type Neoplasms by Site Neoplasms, Glandular and Epithelial Otorhinolaryngologic Diseases Otorhinolaryngologic Neoplasms Pharyngeal Diseases Pharyngeal Neoplasms Squamous Cell Carcinoma of Head and Neck Stomatitis Stomatognathic Diseases

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

West China Hospital, Sichuan University

Chengdu, Sichuan, 610041, China

About this study

The goal of this clinical trial is to evaluate the efficacy and safety of Streptococcus salivarius K12 in reducing the incidence, duration, and severity of severe oral mucositis (SOM). The main questions it aims to answer are whether Streptococcus salivarius K12 can effectively prevent and treat radiation-induced oral mucositis and whether it will cause adverse events in patients undergoing radiotherapy.

Participants will be instructed to suck a Streptococcus salivarius K12 or placebo lozenge three times daily from the beginning to the end of RT. After using the lozenges, the patients should avoid eating, drinking and conducting any oral hygiene activities for at least 1 hour.

Researchers will compare Streptococcus salivarius K12 group and placebo group to see if oral probiotic are beneficial in preventing and treating oral mucositis in patients undergoing radiotherapy.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Patients with non-metastatic head and neck malignant tumor diagnosed by histopathology;
  • Aged 18 to 80 years;
  • Systemic functional status Eastern Cooperative Oncology Group (ECOG) (Appendix 1) rating ≤2;
  • Receiving definitive RT or postoperative adjuvant RT at a dose of 60-72Gy with/without concurrent chemotherapy;
  • Sign the informed consent

Exclusion criteria

  • Patients with known allergy to probiotic or severe allergic constitution;
  • Using antibiotics/antifungal drugs within 1 month or using antimicrobial mouthwash within 1 week before the study;
  • Poor oral hygiene and/or severe periodontal diseases;
  • Any previous RT to the head and neck region;
  • Deemed unsuitable for the study by the investigators (concomitant with any other severe diseases).

Treatment and study plan

Streptococcus salivarius K12

Drug

The patients in intervention group were treated with Streptococcus salivarius K12 lozenges three times a day after gargling from the first day of radiotherapy up to 1 week after the end of treatment. Streptococcus salivarius K12 is dissolved in the mouth and then swallowed.

Other names: OralBiotic BLIS K12 (NOW Foods, USA)

Streptococcus salivarius K12 simulants

Drug

Patients in control group were treated with Streptococcus salivarius K12 simulants, and its use method and use time are the same as intervention group.

Primary outcomes

  1. The incidence of Severe Oral mucositis (WHO grade ≥3)

    Time frame: From the start of radiotherapy to 8 weeks after completion of radiotherapy

    Oral mucositis is assessed by trained physicians according to World Health Organization (WHO) oral toxicity Scale.

Secondary outcomes

  1. Taste function

    Time frame: 1 week before radiotherapy ; at the middle of radiotherapy (3 weeks after the start of radiotherapy) ; at the end of radiotherapy (the last radiation dose received, usually 6 or 6.5 weeks); and 1, 3, 6, 9 and 12 months after the end of radiotherapy

    Electrogustometer test and taste strips test.

  2. Xerostomia

    Time frame: 1 week before radiotherapy ; at the middle of radiotherapy (3 weeks after the start of radiotherapy) ; at the end of radiotherapy (the last radiation dose received, usually 6 or 6.5 weeks); and 1, 3, 6, 9 and 12 months after the end of radiotherapy

    Patients self-rated xerostomia according to summated xerostomia inventory (SXI), and researchers measured saliva flow rates.

  3. functional assessment of cancer therapy-head and neck (FACT- H&N) quality of life questionnaire.

    Time frame: 1 week before radiotherapy; at the end of radiotherapy(the last radiation dose received, usually 6 or 6.5 weeks); ; and 1, 3, 6, 9 and 12 months after the end of radiotherapy

    FACT- H&N quality of life questionnaire.

  4. Adverse events

    Time frame: From the first day of radiotherapy to the day of the last radiation dose received, usually 6 or 6.5 weeks

    Common Terminology Criteria for Adverse Events (CTCAE) 5.0 version

  5. The duration of Severe Oral mucositis (WHO grade ≥3)

    Time frame: From the start of radiotherapy to 8 weeks after completion of radiotherapy

    The first determination of SOM to the first instance of non-severe OM (WHO grade <3), without a subsequent instance of SOM. Patients without observed SOM were assigned a duration of 0 days.

  6. The time to onset of Severe Oral mucositis (WHO grade ≥3)

    Time frame: From the start of radiotherapy to 8 weeks after completion of radiotherapy

    Time from the first day of radiotherapy to the first determination of SOM. Patients without observed SOM were assigned onset days of 6 or 6.5 weeks.

  7. The number of patients who missed five or more consecutive radiation fractions.

    Time frame: The time period is the period from the start of radiotherapy to the completion of radiotherapy

    The number of patients who missed five or more consecutive radiations and the reasons for this are recorded during radiotherapy.

  8. Mouth and throat soreness (MTS) scores

    Time frame: The time period is the period from the start of radiotherapy to the completion of radiotherapy.The evaluation period is approximately 6 weeks and 6 1/2 weeks

    Patients report mouth and throat soreness (MTS) scores (Likert scale 1 to 5) via the oral mucositis weekly questionnaire （OMWQ）. Higher score indicates more severe symptoms.

  9. Oral activities scores

    Time frame: The time period is the period from the start of radiotherapy to the completion of radiotherapy. The evaluation period is approximately 6 weeks and 6 1/2 weeks

    Patients report the degree to the impact of MTS on oral activities (including swallowing, drinking, eating, talking, sleeping) (Likert scale 1 to 5) via the oral mucositis weekly questionnaire （OMWQ）. Higher score indicates more severe symptoms.

Sponsors and collaborators

Lead sponsor

West China Hospital

Other

Registry information

Official study title

Streptococcus Salivarius K12 for Prevention and Treatment of Oral Mucositis in Patients Undergoing Radiotherapy for Head and Neck Tumor: A Randomized, Placebo-Controlled, Double-Blind Trial

Important dates

Study start
2022
Primary completion
2022
Study completion
2022
First posted
Jun 26, 2023
Registry last updated
Feb 5, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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